Research Article | Volume: 2 Issue: 9, September, 2012

Development and Validation of RP-HPLC Method for Simultaneous Estimation of Enalapril Maleate and Amlodipine Besylate in Combined Dosage form

Bharat G. Chaudhari   

Open Access    DOI: 10.7324/JAPS.2012.2911

Abstract

A simple, precise and rapid reverse-phase HPLC method has been developed and subsequently validated for the simultaneous estimation of Amlodipine besylate and Enalapril maleate from their combination drug product. The proposed RP-HPLC method utilizes a Phenomenex C18, 5 µm, 250 mm × 4.6 mm i.d. column, at ambient temperature, optimum mobile phase consisted of Methanol: Acetonitrile : Water (40:50:10, v/v/v), effluent flow rate monitored at 1.0 mL min-1, and detection using PDA detector. The described method was linear over the range of 0.5-6.0 g/ml and 0.5-8.0 g/ml for Enalapril maleate and Amlodipine besylate, respectively. The mean recovery was found to be 100.06 ± 0.49 % and 99.98 ± 0.63 % for Enalapril maleate and Amlodipine besylate, respectively. The intermediate precision data obtained under different experimental setup, the calculated value of coefficient of variation (CV, %) was found to be less than critical value. The proposed method can be useful in the quality control of bulk manufacturing and pharmaceutical dosage forms.


Keyword:     Enalapril maleate Amlodipine besylate RP-HPLC Validation.


Citation:

Bharat G. Chaudhari. Development and Validation of Rp-Hplc Method for Simultaneous Stimation of Enalapril Maleate and Amlodipine Besylate in Combined Dosage form J App Pharm Sci. 2012; 2(9): 054-057.

Copyright:The Author(s). This is an open access article distributed under the Creative Commons Attribution Non-Commercial License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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